Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

15026–15050 of 27762

HighFDA (Devices)·Z-0518-2024·2023-12-20
Iconix Knotless 1.4mm Anchor recalled due to inserter failure risk
Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.
Product
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wri
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0577-2024·2023-12-20
Greek Feta Dressing and Related Products Recalled for Temperature Abuse
Ben E Keith Foods is recalling Greek Feta dressing and other refrigerated and frozen foods shipped in a temperature-abused trailer, affecting 1,721 cases total. No illnesses have been reported.
Product
DRESSING GREEK FETA
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0543-2024·2023-12-20
Medical Diagnostic System Recall Due to Software-Related System Freezes and Delayed Results
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.
Product
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2024·2023-12-20
Cardinal Health Stool Transportation System Recalled for Vial Leakage
Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.
Product
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2024·2023-12-20
Brachytherapy Treatment Planning Software Recalled Due to Measurement Inaccuracy
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
Product
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0534-2024·2023-12-20
Medline Leg Bags Recalled Due to Undeclared Latex
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
Product
Medline Leg bag, REF DYND12578
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0516-2024·2023-12-20
FDA Recalls 4Kscore Prostate Cancer Diagnostic Test Over Model Concerns
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
Product
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0555-2024·2023-12-20
CARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings
The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.
Product
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0571-2024·2023-12-20
Frozen shrimp and other foods recalled due to temperature abuse
Ben E Keith Foods is recalling frozen and refrigerated shrimp and other food products that were temperature abused while stored in a food trailer. The products were distributed to food service establishments.
Product
SHRIMP RAW P&D WHITE 16-20 CT
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0531-2024·2023-12-20
Povidone Solution Labeled Sterile Despite Non-Sterile Contents
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Product
STERILE POVIDONE, REF DYNDA2061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0550-2024·2023-12-20
Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures
Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.
Product
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0553-2024·2023-12-20
X-ray system overhead suspension components may fall due to incorrect bolt torque
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
Product
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0148-2024·2023-12-20
Penicillamine Tablets Recalled Due to Failed Dissolution Specifications
Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.
Product
PENICILLAMINE — PENICILLAMINE (PENICILLAMINE)
Category
Drug
Distribution
0 states
HighFDA (Food)·F-0575-2024·2023-12-20
Frozen Vegetable Products Recalled Due to Temperature Abuse During Transport
Ben E Keith Foods is recalling approximately 1,721 cases of multiple frozen vegetable and side-dish products due to temperature abuse during shipment. Consumers should discard affected products.
Product
TATER KEG BACON CHEDDAR CHIVE; OKRA CUT HEAVILY BREADED IQF; POTATO TATER TOTS; FRENCH FRIES SC 3/8 IN; JALAPENO STUFFED W/CHDR CHS; CORN CUT; BEAN GREEN REGULAR CUT; BEAN GREEN SPICY BREADED; ONION RING BEER BATTERED 5/8IN; PICKLE FRIES BREADED MUSHROOM BATTERED
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0545-2024·2023-12-20
Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.
Product
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0552-2024·2023-12-20
GE Definium Tempo X-Ray System Bolts May Loosen and Fall
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.
Product
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2024·2023-12-20
Sterile PVP Solution Kit Recalled for Non-Sterile Contents
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
Product
STERILE PVP SLN KIT, REF DYNDM1097
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2024·2023-12-20
FDA Recalls Medline Leg Bags for Undeclared Latex
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
Product
Medline Leg bag, REF DYND12574
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0525-2024·2023-12-20
Medline Sterile PVP Solution Recalled Due to Non-Sterile Contents
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
Product
STERILE PVP SOLUTION, REF DYNDA1907
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0510-2024·2023-12-20
Wilcox Premium Coffee Recalled Due to Listeria Contamination
Wilcox Premium Coffee products with Best By dates from September 14 to November 14, 2024, may be contaminated with Listeria monocytogenes. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York.
Product
Wilcox Premium Coffee; 4 oz Cup; UPC 04372600403; Wilcox Premium Coffee in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-0527-2024·2023-12-20
Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.
Product
STERILE STERILE PREP STICK, REF DYNDA1134
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2024·2023-12-20
Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
Product
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Category
Medical Device
Distribution
5 states
HighFDA (Food)·F-0660-2024·2023-12-20
Gaw's Ham & Cheddar Bagels recalled due to undeclared sesame allergen
Gaws Gourmet Foods is recalling Gaw's Ham & Cheddar Bagels due to undeclared sesame. The product label does not list sesame, posing a risk to consumers with sesame allergies.
Product
Gaw's Ham & Cheddar Bagel 6oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600500
Category
Food
Distribution
1 state
HighFDA (Food)·F-0567-2024·2023-12-20
Sheetz snack mix recalled for undeclared soy allergen
Sheetz M.T.go! Double Dipped Chocolatey Peanut Butter Peanuts Snax Mix is being recalled because it contains undeclared soy. The product was distributed in North Carolina, Virginia, and West Virginia.
Product
Top Label Reads: SHEETZ M.T.go! Made"To"Go DOUBLE DIPPED CHOCOLATEY PEANUT BUTTER PEANUTS SNAX MIX NET WT 6.55 OZ (186 G) Back Panel Reads: SWEET & SPICY SNAX MIX DISTRIBUTED BY SHEETZ DISTRIBUTION SERVICES, LLC. CLAYSBURG, PA 16625 UPC 7 59465 00629 3
Category
Food
Distribution
3 states
HighFDA (Food)·F-0504-2024·2023-12-20
Tyson 2.0 Kava and Kratom Supplement Recalled for Unapproved Additive and pH Control Failure
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend because the product contains kratom, an unapproved food additive, and has a pH level exceeding the required maximum for acidified products.
Product
TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, Mocha, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extract (30%) 120mg, (Providing 36mg Mitragynine), www.tyson20global.com, LGNDS, LLC, UPC: 850043583608, POWERED BY LGNDS, 12 bottles of 2oz each per case.
Category
Food
Distribution
0 states

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15026–15050 of 27762